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Economic Evaluation in Cardiology: Remote Monitoring of Pacemakers

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ClinicalTrials.gov Identifier: NCT02234245
Recruitment Status : Completed
First Posted : September 9, 2014
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Antonio Lopez Villegas, Universidad de Almeria

Brief Summary:

The purpose of this research is to estimate the outcomes in health and cost of the follow-up of patients with pacemakers.

The initial hypothesize of this study is that remote monitoring of pacemaker will show a best relation of outcomes in costs and effectiveness than the conventional follow-up in hospital.


Condition or disease Intervention/treatment Phase
Cardiovascular Disease Device: Telemedicine System Not Applicable

Detailed Description:

Cardiovascular Diseases are a major cause of global morbidity and mortality, being responsible according to the World Health Organization of the 30% of overall mortality.

Since 2001 that the first pacemaker of remote monitoring was implanted in Europe, more than 300,000 pacemaker have been implanted around the world. Despite this sharp expansion, the scientific evidence on economic evaluations of pacemaker with remote monitoring is very limited, and in our knowledge, studies including informal costs have not been conducted.

In the field of cardiology, telemedicine allows consultations with patients through monitoring systems and remote communication analyzing the ongoing heart rates of people with pacemakers, implantable cardioverter defibrillators, cardiac resynchronization therapy and subcutaneous Holter. The use of remote monitoring may save time and efforts to both healthcare professionals and patients, including their informal caregivers, reducing the number of follow up visits to the hospital and reducing the associated costs with patient follow-up, which will help to improve sustainability of healthcare services.

During the 12 months of study, the patients with implant of pacemakers of both groups will be assessed of the same parameters, in 4 different moments (pre-implant and months 1, 6, 12 and 5 years post-implantation).

The study will estimate: 1) The Clinical features of the patients. 2) The effectiveness through of administration of health-related quality of life, functional capacity questionnaires and 3) Finally, the hospital and informal costs of patients with pacemakers will be estimated by the researches.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Economic Evaluation in Cardiology: Remote Monitoring of Pacemakers
Study Start Date : October 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Hospital monitoring of pacemakers
Patients have to go to the hospital to be monitorized
Experimental: Remote monitoring of pacemakers

Telemedicine System:

Patients have not to go to the hospital to be monitorized

Device: Telemedicine System
Telemedicine System is used in remote monitoring group
Other Name: Patients are monitorized from hospital




Primary Outcome Measures :
  1. Clinical features [ Time Frame: 12 months ]

    Selected variables from the medical history records:

    • gender
    • age
    • indication for the implantation of the pacemaker.
    • comorbidities
    • pharmacological treatment
    • vital signs
    • pacemaker parameters


Secondary Outcome Measures :
  1. Health-Related Quality of Life [ Time Frame: 5 years ]
    EuroQol-5Dimensions (EQ-5D)

  2. Functional capacity [ Time Frame: 5 years ]
    Duke Activity Status Index (DASI).

  3. Direct costs [ Time Frame: 5 years ]

    Direct costs taken into account:

    • pacemakers' costs´(device implanted)
    • hospitalizations' costs
    • consultations' costs (hospital)
    • prescribed medical transport's cost
    • health personnel costs
    • pharmaceutical costs

  4. Indirect cost [ Time Frame: 5 years ]

    Maintenance of the medical consultation (hospital):

    • electricity
    • cleaning
    • furniture
    • Health fungible
    • equipment investment

  5. Informal costs [ Time Frame: 5 years ]

    Costs related to the care and displacements of patients to hospital:

    • displacement costs to hospital
    • Accommodation costs
    • Cost of meals
    • Costs for caregivers

  6. Number of patients with Adverse Events [ Time Frame: 5 years ]

    Number of patients with Adverse Events

    - type of Adverse Events diagnosed


  7. Consultations and Hospitalizations unscheduled [ Time Frame: 5 years ]
    - number of unscheduled visits and hospitalizations



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be 18 years of age
  • Have a pacemaker implanted
  • Understand and be able to properly perform self-monitoring at home

Exclusion Criteria:

  • Be participating in another study
  • Refuse to participate in the study
  • Have implanted a different cardiac device to the pacemaker

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02234245


Locations
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Spain
Hospital de Poniente
El Ejido, Almeria, Spain, 04700
Sponsors and Collaborators
Universidad de Almeria
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Antonio Lopez Villegas, PhD student, Universidad de Almeria
ClinicalTrials.gov Identifier: NCT02234245    
Other Study ID Numbers: CEIC-AL 53/2012
First Posted: September 9, 2014    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Keywords provided by Antonio Lopez Villegas, Universidad de Almeria:
Follow-Up studies
Biological Pacemakers
Telemedicine
Efficiency
Additional relevant MeSH terms:
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Cardiovascular Diseases